Protein, Peptide and Glycoprotein Analysis

RSSL have the expertise in peptide, protein and glycosylation analysis to guide you through the various analytical steps required to fully characterise your biomolecule.

Although the majority of biological products in development are based on a monoclonal antibody framework, a significant number of existing and new therapies are not antibody based. These fall broadly into four categories:

Enzyme replacement therapies

Hormones, cytokines and cell growth factors

Blood factors

Non antibody scaffolds

ICH Q6B is the overarching guideline for defining the characterisation, comparability and release testing requirements of these molecules.

Non-antibody proteins vary in their complexity. Glycosylation patterns of antibodies are relatively simple because an antibody has only one glycan site on each heavy chain with a simple glycosylation profile. However, proteins with multiple glycosylation sites will require glycan release from each of these sites, coupled with analysis and structural characterisation. Typically, a more diverse and complex range of glycans are observed, requiring a greater level of analysis, and more complex data interpretation.

During development a bank of knowledge is acquired about the active molecule, including details of the batch-to-batch variability. This is used later to demonstrate adequate control over the manufacturing process. If variability is low, a regulator may permit later reduction in analytical burden, but to do this the manufacturer must demonstrate that changes in the protein glycan profile do not alter the core functionality of the product nor lead to any adverse patient reactions.

RSSL have the expertise in peptide, protein and glycosylation analysis to guide you through the various analytical steps required to fully characterise your biomolecule. RSSL expertise extends beyond the current norm of antibody analysis to the more complex interpretation and understanding of non-antibody-based biomolecules. Though many of the methods used are similar for antibody and non-antibody scaffolds, it is RSSL’s ability to fulfill the requirements of more complex studies that differentiate our experimental offerings.

Make an Enquiry

First Name

Last Name

Title

Company

Phone Number

Email Address

Message

We value your trust when sharing your personal data with us. We always treat
your data in a fair and respectful manner limited to the purpose above
mentioned. If you would like to know more about how we handle your data,
please read our
privacy notice

This website uses cookies to help us give you the best experience when you visit. For more information on our use of cookies and how we manage them, please review our
cookie policy.
By continuing to navigate on this website or clicking on the button you accept our policy regarding the usage of cookies on our privacy notice page